Rheumatoid Arthritis Clinical Trial
The currently recruiting trial listed on CureClick for rheumatoid arthritis is a clinical study for a biosimilar medication. We have received several messages about this trial so we wanted to post some additional information:
According to the FDA, “Biosimilars are a type of biological product that are licensed (approved) by FDA because they are highly similar to an already FDA-approved biological product, known as the biological reference product (reference product), and have been shown to have no clinically meaningful differences from the reference product.”
For this trial, one group will be given the currently approved and available medication Rituxan® (rituximab) and the other will be on a biosimilar version of rituxumab. Neither group will receive a placebo. The goal of the trial is to see if the study drug is as safe and effective in patients with rheumatoid arthritis and attempt to show it has no clinically meaningful difference to the reference product (Rituxan®).
MORE ABOUT THE STUDY FROM THE SPONSOR:
The purpose of this study is to compare the proposed biosimilar study drug rituximab (GP2013) against a standard approved treatment rituximab (Rituxan®) to see if the study drug is as safe and effective in patients with rheumatoid arthritis.
- The study drug (GP2013 and Rituximab) is administered by IV Injection (IV).
- At least 174 people have already taken this drug in clinical trials
- All study related medications, analysis, hospital visits and procedures are free
- be at least 18 years old
- have been diagnosed with rheumatoid arthritis for at least 6 months
- have had inadequate response or intolerance to DMARDs (disease-modifying anti-rheumatic drugs) and 1 – 3 anti-TNF (tumor necrosis factor) therapies
- have received methotrexate for at least 4 months with 25 mg/week as the maximal dose
Participants must not:
- have significant liver disease, or congestive heart failure
- be taking a high potency of opioid analgesics (e.g. methadone, hydromorphone, morphine)
For more information about the study, please visit the link provided to you by your Ambassador.
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